Time Restricted EatingHLNCT06188754
Healthy Lifestyles for Bipolar Disorder
A study testing Time restricted eating and Mediterranean diet in people with Time Restricted Eating and Diet, Mediterranean, run by University of California, Berkeley at 1 site in United States.
Trial summary
The goal of this clinical trial is to compare the effects of two different healthy lifestyles on outcomes for those with bipolar disorder. The goals are to understand the acceptability of time-restricted eating and the mediterranean diet for those who are already receiving medication treatment for bipolar disorder… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Time Restricted Eating, Diet, Mediterranean
- What is being tested?
- Time restricted eating and Mediterranean diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2024to 28 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- meets diagnostic criteria for bipolar I disorder or bipolar II disorder (but not cyclothymia, BD Not otherwise specified or BD due to another medical condition)
- current sleep (insomnia, hypersomnolence) or circadian sleep-wake (delayed phase, advanced phase, irregular sleep-wake, non-24-hour sleep-wake-type) concerns indicated by endorsement of at least some sleep or circadian-related impairment across the screening self-reports or interview
- Living in an English-speaking country (and one that we have expertise in research procedures and diet)
- Has been speaking English for at least 10 years, speaks English in the home, or certifies that they are able to understand English well for the study and demonstrates this during the screening interview.
- Receiving medical care for BD (referrals will be provided for those who would like to begin care)
- Mood-stabilizing medication regimens stable for at least one month
Show all 12Show fewer
- < 5 kg weight change in the past 3 months
- Currently eating ≥ 12 hours per day at least twice per week
- Able to operate the camera function and respond to web-based surveys by phone (loaner phones will be provided as needed)
- Not engaged in current shift work or have other responsibilities such as providing care that would chronically disrupt their sleep (i.e., > 3 h between 22:00 and 05:00 h for at least 1 day/week)
- Able to complete 7 days of dietary logs adequately (e.g., at least 2 entries per day, covering at least a 5-hour eating window) during the baseline period
- Able to complete screening and baseline questionnaires adequately (e.g., not failing more than 1 attention check item with instructed responding; responding to standard multiple-choice items in a mean of < 2 seconds per item). Where individuals respond to more than 14 items in a row with the same response, we will manually review for possible invalidity.
Who cannot join
- Current episode of depression, hypomania or mania, or psychosis (assessed by the aDiagnostic Interview for Anxiety, Mood, and Obsessive-compulsive and Related Neuropsychiatric Disorders; DIAMOND), Participants with acute mood disorder episodes will be encouraged to seek treatment and to consider the study when symptoms have remitted.
- Eating disorder diagnosis (by self-report of treatment or diagnosis at any point during their life, Short Eating Disorder Examination Questionnaire (EDE-QS) scores above clinical concern thresholds for eating disorders, or DIAMOND interview of symptoms during adulthood)
- Past 3-month alcohol use disorder or substance use disorder (assessed by DIAMOND)
- Active suicidal ideation coupled with plan, intent or attempt history as assessed by Columbia Suicide Severity Rating Scale
- Conditions that would interfere with ability to take part in the intervention , including pregnancy, breastfeeding, uncorrected hypo or hyperthyroidism, gastrointestinal conditions impairing nutrient absorption,
- Medical conditions such as HIV, AIDS, lupus, or multiple sclerosis that could confound the assessment of mania or other measures
- Medications contraindicated for fasting: clozapine, glucose-lowering medications, diabetes-related injections, medications requiring food early morning or late evening, corticosteroids; medications such as semaglutide will not be an exclusion criteria
- Cognitive deficits as noted during the initial interview or as indicated by low performance on the Short Orientation Memory Concentration Test (< 20 on the weighted score).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California
Berkeley, California, 94720
Sheri L Johnson, 4153476755, sljohnson@berkeley.edu
About this study
Official title: Time-restricted Eating vs. Mediterranean Diet as Adjunctive Interventions for Bipolar Disorder
The goal of this clinical trial is to compare the effects of two different healthy lifestyles on outcomes for those with bipolar disorder. The goals are to understand the acceptability of time-restricted eating and the mediterranean diet for those who are already receiving medication treatment for bipolar disorder, and to consider how these two food plans predict changes in manic symptoms, depressive symptoms, and Quality of Life. Participants will complete daily measures of eating, sleep and mood for two weeks, and then will be assigned to follow one of the two food plans for eight weeks. The investigators will measure symptoms and Quality of Life at baseline and during and after the food plan.
Read the detailed description
The investigators will conduct a randomized controlled trial (RCT) to examine the effects of time-restricted eating as compared to the mediterranean diet. In time-restricted eating (TRE), participants will be asked to limit their food intake to a period of 10 hours per day. In the mediterranean diet, participants will be asked to follow a food plan that emphasizes vegetables, fruit, whole grains, and olive oil as central dietary components. The investigators aim to test both food plans as additions to standard medication approaches in bipolar disorder. Participants who are receiving medical treatment for bipolar disorder and who report at least some sleep or circadian problems will complete baseline measures and then will be randomly assigned to TRE or the mediterranean diet for 8 weeks, and then will complete measures of symptoms, Quality of Life, and possible treatment mechanisms at the end of treatment and at 3, 6 and 12 months after the intervention. If successful, this work will provide a novel, easily implemented and highly acceptable intervention for BD.
- Conditions
- Time Restricted Eating, Diet, Mediterranean
- Being tested
- Time restricted eating, Mediterranean diet
- Keywords
- bipolar disorder, sleep, circadian rhythm
- Medical subject headings
- Intermittent Fasting, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time restricted eatingBehavioural
Also called intermittent fasting
Limiting food intake to 10 hours per day
Mediterranean dietBehavioural
Dietary advice designed to improve consumption of vegetables, fruits, whole grains, and the use of olive oil.
| Study group | Role | What they receive |
|---|---|---|
| Time Restricted Eating (TRE) for 8 weeks | Experimental | Participants will receive an intro to TRE and then throughout 8 weeks they will receive brief online psychoeducation several times per week with optional weekly coaching sessions. TRE involves restricting the window of eating to 10 hours/ day, most typically by avoiding eating in the first 1-2 hours after awakening and in the 2-4 before sleep. Those with an eating window > 14 hours will be asked to restrict their eating to 12 hours in the first week, then 10 hours in week 2. To select the period, investigators will ask Ss to review baseline logs to consider sleep, eating, family meals and social commitment schedules, and any special energy demands, such as exercise. During the eating window, no restrictions are placed on the type or quantity of food consumed. The investigators will instruct participants to follow their habitual diet within their 10-hour eating window and to aim to consume the same number of calories per day as they did at baseline. Receives: Behavioral: Time restricted eating |
| Mediterranean diet for 8 weeks | Active comparator | Participants will receive a several page introduction to the mediterranean diet, and then will receive support throughout the 8 week intervention to follow this food plan, including brief online psychoeducation that will be sent several times per week, and optional weekly coaching sessions.
The mediterranean diet is a plan for healthy eating based on how people eat in the mediterranean region. Individuals will be encouraged to consume vegetables (6 servings/day), fruits (2-4 servings/day), whole grains (daily), legumes (3-4 times per week), nuts (.5 oz per day), and oily fish (2 servings/week). Participants will be encouraged to choose lean meats and other sources of protein over red meat and processed meats. Sweets, refined cereals, alcohol, and wine or alcohol will be labelled as extras, and participants will be encouraged to limit consumption of extras. Receives: Behavioral: Mediterranean diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability
Participant self-ratings of the acceptability of the intervention: The primary index of acceptability will be the percentage of individuals who endorse that they agree or strongly agree that they would recommend the food plan to a friend. This single item has been used in previous trials of bipolar disorder. Higher agreement will be considered a positive outcome.
Measured: immediately post-treatment (10 weeks after enrollment)
Adherence to time-restricted eating
Adherence will be scored based on the time of their first and final calorie consumption each day during the 8 week intervention. The investigators will select entries from the time interval that contains 95% of intake events. Following standards in other US and European studies of TRE, the investigators will focus on days in which participants adequately logged (e.g., entered at least two intake events, covering at least a 5 hour window), and will calculate the percentage of days in which individuals met the eating window goal. High adherence will be defined as meeting this standard on at least 78% of days logged. As supplemental data, the investigators will report the percentage of days logged, and the percentage of days in which individuals logged adequately and followed the planned window.
Measured: Average number of daily food logs showing adherence across the 8-week intervention
Adherence to Mediterranean Diet
Adherence will be scored based on a Food Frequency Questionnaire that we developed for this study. We will score this using the Adherence to the Mediterranean Diet scoring system (AMed), which provides up to 9 points based on above-median consumption of beneficial foods (e.g., fruits and vegetables) and below median consumption of "extras" such as alcohol. Higher scores reflect better adherence to the mediterranean diet.
Measured: Average number of food logs showing adherence at or above the median for 2 days at the mid-point of treatment (week 6) and at the end of treatment (week 10)
Mania
Decline in Young Mania Rating Scale (YMRS) total scores, completed by a blind rater
Measured: Lower YMRS at the end of intervention (10 weeks) as compared to baseline
Depression
Decline in Montgomery Asberg Depression Scale (MADRS) total scores, completed by a blind rater
Measured: Lower MADRS at the end of intervention (10 weeks) as compared to baseline
Self-rated Quality of Life (QOL)
Higher scores on the self-rated Brief Quality of Life in Bipolar Disorder (QoL.BD) at 1.5-months post intervention as compared to baseline
Measured: Scores at 1.5-months post-intervention (16 weeks after study entry) as compared to baseline
Mania at follow-up
Sustained lower YMRS scores across follow-up
Measured: YMRS scores will be lower at 3, 6, 12 month post-intervention follow-ups as compared to baseline
Depression at follow-up
Sustained lower MADRS scores across follow-up
Measured: MADRS scores will be lower at 3, 6, 12 month post-intervention follow-ups as compared to baseline
QOL at follow-up
Sustained higher Brief QOL.BD scores
Measured: Brief QOL.BD scores will be higher at 6- and 12-month post-intervention follow-ups as compared to baseline
Secondary outcomes (8)
Self-rated mania
Lower Patient Health Questionnaire (PHQ) Mania scores at post-intervention (10 weeks) and at 1.5, 3, 6, and 12 month follow-ups post-intervention
Measured: at post-intervention (10 weeks) and at 1.5, 3, 6, and 12 month follow-ups post-intervention, as compared to baseline
Self-rated depression
Lower Patient Health Questionnaire (PHQ) Depression scores at post-intervention (10 weeks) and at 1.5, 3, 6, and 12 month follow-ups post-intervention
Measured: at post-intervention (10 weeks) and at 1.5, 3, 6, and 12 month follow-ups post-intervention, as compared to baseline
Sleep hygiene behaviors
Lower scores on the Sleep Household Environment and In-Bed Behaviors at end-of-treatment (10 weeks) as compared to baseline
Measured: post-intervention (10 weeks) as compared to baseline
Weekly change in mania severity
Lower Longitudinal Interval Follow-up Evaluation (LIFE) weekly Mania scores post-treatment as compared to those at baseline. The investigators will administer the LIFE interview at 3, 6, and 12-months after the intervention, and interviewers will record a mania severity rating for each week, to cover the time from the end of intervention until one year after the intervention ends.
Measured: Weekly scores from the end of the intervention through one-year post-intervention follow-up
Sleep disturbance and sleep impairment
Lower scores on the Patient Outcomes Reporting Information System (PROMIS) sleep disturbance and sleep impairment scores at post-treatment (10 weeks) as compared to baseline
Measured: post-treatment (10 weeks) as compared to baseline
Sleep mid-point variability (Munich Chronotype Questionnaire; MCTQ)
MCTQ scores will show a smaller proportion of individuals with either early or delayed chronotype (as reflected in standard scoring for the MCTQ) at post-treatment as compared to baseline
Measured: post-treatment (10 weeks) as compared to baseline
Regularity of daily routines (Brief Social Rhythm Questionnaire)
Lower Brief Social Rhythm Questionnaire scores (less irregularity) at post-treatment as compared to baseline
Measured: post-treatment (10 weeks) as compared to baseline
Daily emotional lability as assessed using ecological momentary assessment
Lower mean square of successive difference of negative affect scores within derived from the ecological momentary assessments at the mid-point of treatment (6 weeks) as compared to baseline. Participants will be asked to complete negative affect ratings several times per day for 8 days, at the baseline and mid-point of treatment. The investigators will calculate scores to examine the degree of negative affect variability for each day, and then take the average across 8 days at baseline and at treatment mid-point.
Measured: mid-point of treatment (6 weeks post study entry) as compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start5 Jun 2024
- Primary completion28 Dec 2028 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Time Restricted EatingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to take part in either time-restricted eating or the Mediterranean diet.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Berkeley
- Sponsor type
- University, hospital or other
- Collaborators
- University College, London, Swinburne University of Technology, Deakin University, University of British Columbia, Salk Institute for Biological Studies, Wellcome Trust
- Responsible party
- Sponsor
- Investigators
- Sheri L Johnson, PhD, Principal investigator, University of California, Berkeley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06188754
- Sponsor's protocol ID
- Healthy Lifestyles 01
- Acronym
- HL
- Status last verified
- Jul 2026
- First submitted
- 18 Dec 2023
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Measures, data, and analysis scripts will be shared through Open Science Foundation.
Publications
Johnson SL, Murray G, Kriegsfeld LJ, Manoogian ENC, Mason L, Allen JD, Berk M, Panda S, Rajgopal NA, Gibson JC, Joyner KJ, Villanueva R, Michalak EE. A randomized controlled trial to compare the effects of time-restricted eating versus Mediterranean diet on symptoms and quality of life in bipolar disorder. BMC Psychiatry. 2024 May 18;24(1):374. doi: 10.1186/s12888-024-05790-4.
PubMed 38762486
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time-restricted Eating vs. Mediterranean Diet as Adjunctive Interventions for Bipolar Disorder
- ClinicalTrials.gov ID
- NCT06188754
- Acronym / sponsor ID
- HL / Healthy Lifestyles 01
- Conditions
- Time Restricted Eating, Diet, Mediterranean
- Keywords
- bipolar disorder, sleep, circadian rhythm
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of California, BerkeleyUniversity, hospital or other
- Collaborators
- University College, London, Swinburne University of Technology, Deakin University, University of British Columbia, Salk Institute for Biological Studies, Wellcome Trust
- Study start
- 5 Jun 2024 (actual)
- Primary completion
- 28 Dec 2028 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 3 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to compare the effects of two different healthy lifestyles on outcomes for those with bipolar disorder. The goals are to understand the acceptability of time-restricted eating and the mediterranean diet for those who are already receiving medication treatment for bipolar disorder, and to consider how these two food plans predict changes in manic symptoms, depressive symptoms, and Quality of Life. Participants will complete daily measures of eating, sleep and mood for two weeks, and then will be assigned to follow one of the two food plans for eight weeks. The investigators will measure symptoms and Quality of Life at baseline and during and after the food plan.
Detailed description
The investigators will conduct a randomized controlled trial (RCT) to examine the effects of time-restricted eating as compared to the mediterranean diet. In time-restricted eating (TRE), participants will be asked to limit their food intake to a period of 10 hours per day. In the mediterranean diet, participants will be asked to follow a food plan that emphasizes vegetables, fruit, whole grains, and olive oil as central dietary components. The investigators aim to test both food plans as additions to standard medication approaches in bipolar disorder. Participants who are receiving medical treatment for bipolar disorder and who report at least some sleep or circadian problems will complete baseline measures and then will be randomly assigned to TRE or the mediterranean diet for 8 weeks, and then will complete measures of symptoms, Quality of Life, and possible treatment mechanisms at the end of treatment and at 3, 6 and 12 months after the intervention. If successful, this work will provide a novel, easily implemented and highly acceptable intervention for BD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to take part in either time-restricted eating or the Mediterranean diet.
| Arm | Type | Receives |
|---|---|---|
| Time Restricted Eating (TRE) for 8 weeks | Experimental | Behavioral: Time restricted eatingParticipants will receive an intro to TRE and then throughout 8 weeks they will receive brief online psychoeducation several times per week with optional weekly coaching sessions. TRE involves restricting the window of eating to 10 hours/ day, most typically by avoiding eating in the first 1-2 hours after awakening and in the 2-4 before sleep. Those with an eating window > 14 hours will be asked to restrict their eating to 12 hours in the first week, then 10 hours in week 2. To select the period, investigators will ask Ss to review baseline logs to consider sleep, eating, family meals and social commitment schedules, and any special energy demands, such as exercise. During the eating window, no restrictions are placed on the type or quantity of food consumed. The investigators will instruct participants to follow their habitual diet within their 10-hour eating window and to aim to consume the same number of calories per day as they did at baseline. |
| Mediterranean diet for 8 weeks | Active comparator | Behavioral: Mediterranean dietParticipants will receive a several page introduction to the mediterranean diet, and then will receive support throughout the 8 week intervention to follow this food plan, including brief online psychoeducation that will be sent several times per week, and optional weekly coaching sessions. The mediterranean diet is a plan for healthy eating based on how people eat in the mediterranean region. Individuals will be encouraged to consume vegetables (6 servings/day), fruits (2-4 servings/day), whole grains (daily), legumes (3-4 times per week), nuts (.5 oz per day), and oily fish (2 servings/week). Participants will be encouraged to choose lean meats and other sources of protein over red meat and processed meats. Sweets, refined cereals, alcohol, and wine or alcohol will be labelled as extras, and participants will be encouraged to limit consumption of extras. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- meets diagnostic criteria for bipolar I disorder or bipolar II disorder (but not cyclothymia, BD Not otherwise specified or BD due to another medical condition)
- current sleep (insomnia, hypersomnolence) or circadian sleep-wake (delayed phase, advanced phase, irregular sleep-wake, non-24-hour sleep-wake-type) concerns indicated by endorsement of at least some sleep or circadian-related impairment across the screening self-reports or interview
Key exclusion criteria (8 listed)
- Current episode of depression, hypomania or mania, or psychosis (assessed by the aDiagnostic Interview for Anxiety, Mood, and Obsessive-compulsive and Related Neuropsychiatric Disorders; DIAMOND), Participants with acute mood disorder episodes will be encouraged to seek treatment and to consider the study when symptoms have remitted.
- Eating disorder diagnosis (by self-report of treatment or diagnosis at any point during their life, Short Eating Disorder Examination Questionnaire (EDE-QS) scores above clinical concern thresholds for eating disorders, or DIAMOND interview of symptoms during adulthood)
- Past 3-month alcohol use disorder or substance use disorder (assessed by DIAMOND)
- Active suicidal ideation coupled with plan, intent or attempt history as assessed by Columbia Suicide Severity Rating Scale
- Conditions that would interfere with ability to take part in the intervention , including pregnancy, breastfeeding, uncorrected hypo or hyperthyroidism, gastrointestinal conditions impairing nutrient absorption,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time restricted eatingAlso: intermittent fastingLimiting food intake to 10 hours per day | Behavioural | Time Restricted Eating (TRE) for 8 weeks |
| Mediterranean dietDietary advice designed to improve consumption of vegetables, fruits, whole grains, and the use of olive oil. | Behavioural | Mediterranean diet for 8 weeks |
Primary outcome
Acceptability
Time frame: immediately post-treatment (10 weeks after enrollment)
Participant self-ratings of the acceptability of the intervention: The primary index of acceptability will be the percentage of individuals who endorse that they agree or strongly agree that they would recommend the food plan to a friend. This single item has been used in previous trials of bipolar disorder. Higher agreement will be considered a positive outcome.
Adherence to time-restricted eating
Time frame: Average number of daily food logs showing adherence across the 8-week intervention
Adherence will be scored based on the time of their first and final calorie consumption each day during the 8 week intervention. The investigators will select entries from the time interval that contains 95% of intake events. Following standards in other US and European studies of TRE, the investigators will focus on days in which participants adequately logged (e.g., entered at least two intake events, covering at least a 5 hour window), and will calculate the percentage of days in which individuals met the eating window goal. High adherence will be defined as meeting this standard on at least 78% of days logged. As supplemental data, the investigators will report the percentage of days logged, and the percentage of days in which individuals logged adequately and followed the planned window.
Adherence to Mediterranean Diet
Time frame: Average number of food logs showing adherence at or above the median for 2 days at the mid-point of treatment (week 6) and at the end of treatment (week 10)
Adherence will be scored based on a Food Frequency Questionnaire that we developed for this study. We will score this using the Adherence to the Mediterranean Diet scoring system (AMed), which provides up to 9 points based on above-median consumption of beneficial foods (e.g., fruits and vegetables) and below median consumption of "extras" such as alcohol. Higher scores reflect better adherence to the mediterranean diet.
Mania
Time frame: Lower YMRS at the end of intervention (10 weeks) as compared to baseline
Decline in Young Mania Rating Scale (YMRS) total scores, completed by a blind rater
Depression
Time frame: Lower MADRS at the end of intervention (10 weeks) as compared to baseline
Decline in Montgomery Asberg Depression Scale (MADRS) total scores, completed by a blind rater
Self-rated Quality of Life (QOL)
Time frame: Scores at 1.5-months post-intervention (16 weeks after study entry) as compared to baseline
Higher scores on the self-rated Brief Quality of Life in Bipolar Disorder (QoL.BD) at 1.5-months post intervention as compared to baseline
Mania at follow-up
Time frame: YMRS scores will be lower at 3, 6, 12 month post-intervention follow-ups as compared to baseline
Sustained lower YMRS scores across follow-up
Depression at follow-up
Time frame: MADRS scores will be lower at 3, 6, 12 month post-intervention follow-ups as compared to baseline
Sustained lower MADRS scores across follow-up
QOL at follow-up
Time frame: Brief QOL.BD scores will be higher at 6- and 12-month post-intervention follow-ups as compared to baseline
Sustained higher Brief QOL.BD scores
8 secondary outcomes
Self-rated mania
Time frame: at post-intervention (10 weeks) and at 1.5, 3, 6, and 12 month follow-ups post-intervention, as compared to baseline
Self-rated depression
Time frame: at post-intervention (10 weeks) and at 1.5, 3, 6, and 12 month follow-ups post-intervention, as compared to baseline
Sleep hygiene behaviors
Time frame: post-intervention (10 weeks) as compared to baseline
Weekly change in mania severity
Time frame: Weekly scores from the end of the intervention through one-year post-intervention follow-up
Sleep disturbance and sleep impairment
Time frame: post-treatment (10 weeks) as compared to baseline
Sleep mid-point variability (Munich Chronotype Questionnaire; MCTQ)
Time frame: post-treatment (10 weeks) as compared to baseline
Regularity of daily routines (Brief Social Rhythm Questionnaire)
Time frame: post-treatment (10 weeks) as compared to baseline
Daily emotional lability as assessed using ecological momentary assessment
Time frame: mid-point of treatment (6 weeks post study entry) as compared to baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Derived from this study: PubMed 38762486Johnson SL, Murray G, Kriegsfeld LJ, Manoogian ENC, Mason L, Allen JD, Berk M, Panda S, Rajgopal NA, Gibson JC, Joyner KJ, Villanueva R, Michalak EE. A randomized controlled trial to compare the effects of time-restricted eating versus Mediterranean diet on symptoms and quality of life in bipolar disorder. BMC Psychiatry. 2024 May 18;24(1):374. doi: 10.1186/s12888-024-05790-4.
- Individual participant dataSharing planned: Yes. Measures, data, and analysis scripts will be shared through Open Science Foundation.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sheri L Johnson, PhD principal investigator
University of California, Berkeley
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time restricted eating and Mediterranean diet in people with Time Restricted Eating and Diet, Mediterranean, run by University of California, Berkeley at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sheri L Johnson, PhD ((510) 519-4305, calmprogram@berkeley.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability (time frame: immediately post-treatment (10 weeks after enrollment)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06188754, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.